Consulting & Registration

TOXLAB -Global Regulatory Registration Services

We specialize in international registration and compliance support for cosmetics, medical devices, in vitro diagnostics, biocides, agrochemicals, and biopesticides.

Our expertise spans major global regulatory bodies including the USFDA, USEPA, EMA, MHRA, TGA, Health Canada, PMDA, SFDA, and other regional authorities. From dossier preparation to post-approval support, we help you navigate complex regulatory landscapes with confidence and efficiency.

TOXLAB -Consulting & Registration Services India

At TOXLAB, we provide comprehensive regulatory consulting and registration services across key Indian authorities, including CDSCO, ICMR, DSIR, BIS, AYUSH, FSSAI, NPPA, CIB & RC, and NBAIM.

Our expertise covers a wide range of product categories such as drugs and cosmetics, medical devices, in vitro diagnostics, narcotics, agrochemicals, and biopesticides. Whether you are launching a new product or ensuring ongoing compliance, TOXLAB is your trusted partner for navigating India’s complex regulatory ecosystem.

We also offer wide range of services like Regulatory Support, Toxicology, Preclinical & Clinical DMPK, Biology – Efficacy Studies in Animal Models, Medicinal Chemistry, Synthetic Chemistry, Drug Discovery, Drug Development, Metabolite Studies, E-Fate Studies, Agrochemical Discovery & Development and many more.

 

Consulting and Regulatory Services

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Studies) is a regulatory requirement of European Chemical Agency (ECHA). We have experience and expertise in designing the REACH studies as per European Chemical Agency (ECHA) requirements and submission of the data in the International Uniform Chemical Information Database (IUCLID) format.

DRUGS

  • Assists in Import Registration, New Drugs, Subsequent New Drugs,Clinical trials, Dual Use NOC, Test License, Registration & Renewals.

COSMETICS

  • Providing most efficient and comprehensive Regulatory solutions for Registrations of Cosmetics, Renewals, Amendments, Label Reviews

IN VITRO DIAGNOSTICS

  • Suggest Regulatory Direction in the all new MDR Rules. Guidance on Notified and Non Notified Devices, Registrations,Test Licenses and More

MEDICAL DEVICES

  • Provides Tailor Made Regulatory Solutions & Services in the midst of new MDR Rules & Regulations.

INDIAN AGENT REPRESENTATION

  • Offers Bespoke & On-demand Registration holding Services to Global Companies.

NARCOTICS

  • We provides Clear Regulatory pathway Under the Narcotic Drugs and Psychotropic Substances Act, 1985 Regulated by Central Bureau of Narcotics.

NIB NOIDA

  • Offers On-demand Testing Support Services at National Institute of Biologicals,Noida.

CDL KASAULI

  • Offers On-demand Testing Support Services at Central Drugs Laboratory, Kasauli.

VACCINES & BIOLOGICALS

  • We provide Consulting services for Registration and Import Licenses for Vaccines & Biologicals.

DSIR

  • Provides Consulting Services for Recognition under Department of Scientific & Industrial research to Help companies apply for Tax Benefits by having In house recognitions.

NPPA

  • Provides Consulting Services under drug prices control order 1995 – National Pharmaceutical Pricing Authority.

BUREAU OF INDIAN STANDARDS

  • We offers Product Certification Services for Products Covered under ISI & CRS Schemes under Bureau of Indian Standards.

VETERINARY

  • We offer end to end Service for Launching a New Veterinary product in Indifrom CDSCO

FSSAI(FOOD)

  • Offers Quick Submission & Approval under Wireless Planning & Coordination and ETA Approvals

AYUSH

  • We offer Guidance on approval for COPP(Certificate of Pharmaceutical Products) for AYUSH products

NBAIM CULTURE COLLECTION (NAIMCC)

  • Provides Consulting Services for General Deposit of Microorganisms, Safe Deposit of Microorganisms, Registration of Elite Microbes, Patent Deposits of Microorganisms, Supply of Microbial Cultures

CENTRAL INSECTICIDE BOARD(CIB)

  • Provides Consulting Services for Registration of various Pesticides, Insecticides, Fungicides, Herbicides, Household insecticides, Bio Pesticides, Bio-fertilizers and PGR U/s 9(3B), 9(3) & 9(4) of the Insecticides Act, 1968, Govt. of India., Registration under Section 9(4) Formulation, Registration under section 9(4) TIM, Export of Existing / New Technical/Formulations, Registration under Section 9(3)B, Enhancement of Product Shelf Life, Packing, RTT Permit, Endorsement for transfer of cir/Shifting the address/Company name change, Inclusion of products in schedule of Insecticides Act, 1968

AERB (Atomic Energy Regulatory Board) Approvals

  • Our expertise in the area of radioisotope is Radio labelling in general, Design of the radio tracer experiments, Radio iodination, Training in Radioactivity Handling, AERB (Atomic Energy Regulatory Board) Approval Process for use of radio tracer and for establishing Radiotracer Laboratory, Radio-pharmaceuticals,

    Radioimmunoassay, Guidance and identifying radioisotope and labeled compound sourcing, Radio Safety Officer (RSO) Training, RSO Consultants

Request the Client Questionnaire for

COSMETICS

  • US FDA MoCRA Registration
  • EU Cosmetics Registration
  • GCC Cosmetics Registration
  • Indian CDSCO Registration
  • Cosmetics Registration in South East Asian Countries

MEDICAL DEVICES

  • FDA Medical Device Registration
  • CDSCO Medical Device Registration
  • EU Medical Device Registration
  • GCC Medical Device Registration
  • ASEAN Countries Medical Device Registration

TOXLAB: Your Partner in Regulatory Compliance